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Review article

First published 2021-12

Comparison of regulatory dossier requirements for marketing authorization of generic solid dosage forms in the United States and Europe: A review

Lovely Joylein, Bishop Adhikari, Megha Chellath Kottayi [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Other

First published 1998-1

Assembling International Regulatory Submissions: A Simplified Approach

Robert G. Rhorer, Susan Landis, Jesper P. Lorenzen

Therapeutic Innovation & Regulatory Science

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Other

First published 1998-4

Organization and Responsibilities of the Chemistry,Manufacturing,and Controls Function within Regulatory Affairs: A Survey of 17 Companies

Samuel T. Barnett, Roger W. Croswell, Anthony C. Cartwright [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1995-10

The Industry View of International Standardization of Regulatory Dossiers

Helene Dumitriu

Therapeutic Innovation & Regulatory Science

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Research article

First published 2013-3

Technical gaps faced by Chinese generic medicine manufacturers to achieve the standards of WHO medicines Prequalification

Baobin Huang, Sarah L Barber, Milan Smid [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2017-9

Challenges to conclude elemental impurities risk assessment for pharmaceutical dosage form and submission in regulatory dossier

Jignesh Prajapati

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 1990-1

TMO: The Trial Management Organization—A New System for Reducing the Time for Clinical Trials

Karl E. Peace

Therapeutic Innovation & Regulatory Science

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Research article

First published 1997-1

An Integrated Approach to the Preparation of Global CMC Dossiers

Peter C. Karlton, David Johnston

Therapeutic Innovation & Regulatory Science

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Research article

First published 2010-1

Assessment Methodology for Performing Regulatory Due Diligence Based on a Quantitative Approach

Andrey Mladenov, Yuliana Maslarova, Eleonora Petkova [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Review article

First published 2019

An Overview of the Drug Registration Requirements for Export to Tanzania,Nepal,and Cambodia

Triveni V. Shelke, Shyam Khante, Mukund B. Sarda [...]

Therapeutic Innovation & Regulatory Science

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